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Infliximab
Product Approval Information - Licensing Action
Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA, License #1242
Indication for Use: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)
Approval Date: 8/24/98
Type of submission: Biologics license application
Approval Letter (PDF),
(Text)
Label (PDF)
Review Documents
Clinical Review (CBER)
(PDF)
Clinical Review (CDRH)
(PDF)
Clinical Pharmacology
(PDF)
Pharmacology Review
(PDF)
Product Review
(PDF)
Product Review (Attachments 1-8)
(PDF)
Statistical Review
(PDF)
Talk Paper
Last Updated: 3/6/2001
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Updated: September 25, 2003 |
